Mastering the Informed Consent Process

Michael Green, MD, provides information and guidance as to the components and process of informed consent.

Obtaining Informed Consent for Research In Pediatrics

Michael Green, MD: During the next few minutes, we are going to talk about obtaining informed consent to participate in a research study. I want to begin by discussing what informed consent is and is not.

Informed consent is not:

A legal release

A document to limit institutional liabilities

A formality for research, or

A one-time event

Informed consent is:

An interactive process between participant and researcher

A process that is done at every point in the study where there is contact between the participant and the research team, and

Acknowledgment of a person’s autonomy

There are many reasons that we obtain informed consent. These include complying with requirements, such as the Institutional Review Board policies or government regulations.

But just as or more importantly, there are ethical rationales for obtaining informed consent so that we demonstrate respect for the person, establish trust and demonstrate honesty and transparency in the process. In the end, consenting matters to research participants.

While parents and patients may have a number of reasons for participating, it is critical that as part of our consenting process we emphasize that research is NOT medical practice and that we do everything we possibly can to avoid the so-called therapeutic misconception, where parents and patients might conclude that the new treatment being offered in a study will definitely make them better. Although we are usually under pressure to enroll enough research subjects so that the study can be successful and completed, we need to make sure that we do not coerce families or children to say “yes” when we ask them to participate.

Consenting requires us to cover several key components including, but not limited to, the fact that the study involves research and also to provide descriptions of what is involved if the family agrees, as well as to highlight potential risks, benefits, and alternatives to the research treatments.

It is important to note that as the person obtaining consent, your main job is NOT to get the signature agreeing to participate in the study, but rather to assure yourself that the parent or patient understand what it is that they are consenting to and that they recognize that this is research and not a clinical recommendation and that they have a choice about participating.

Things that we can do to assure ourselves that they understand are to use strategies like the talk-back method where we ask open-ended questions throughout the consenting process to confirm that they understand what we are asking and why we are asking them to participate. For those of us involved in pediatrics, we also have the responsibility to assure that the children old enough to understand provide their assent for participation.

In order to achieve these goals, those of us obtaining consent for research need to make sure that we allow ourselves enough time to get consent and also that we create a setting that is neither confused nor chaotic when carrying out the consenting conversation.

The slide set on this website provides specific details and examples of how to best obtain research informed consent. They should help you to optimize your consenting process so that families and patients understand what is being asked of them and why; that they reinforce the fact that medications and interventions that are offered in the research process are not necessarily proven to be the best treatment for their child, and thus help you to avoid the therapeutic misconception. Examples of the kinds of questions that you can ask to assure yourself of this, and to make sure that families understand what they are being asked to do are included.

And finally, I just want to emphasize to you that obtaining informed consent does not end when the family agrees to the study or when the child assents to participate. It is a continuous process that we, as members of the research team, need to do at every visit and contact we have with the family and the child.